NIGHT TIME SINUS AND CONGESTION- acetaminophen, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Night Time Sinus and Congestion by

Drug Labeling and Warnings

Night Time Sinus and Congestion by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Accucaps Industries Limited, Accucaps Industries Limited Strathroy, Legacy Pharmaceutical Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Antihistamine

Nasal decongestion

Uses

• temporarily relieves symptoms due to common cold
• minor aches and pains
• headache
• fever
• runny nose and sneezing  
• nasal congestion
• sinus congestion & pressure
• temporarily relieves symptoms due to hay fever or other upper respiratory allergies
• minor aches and pains
• headache
• runny nose and sneezing
• itching of the nose or throat, and itchy, watery eyes
• nasal congestion
• sinus congestion & pressure

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• to make a child sleep

Ask a doctor before use if

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use ifyou are

• taking sedatives or tranquilizers   
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask doctor if

• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• you get nervous, dizzy or sleepless

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• take only as directed

• adults & children 12 years & over: 2 Liquid Caps with water every 4 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• store at controlled room temperature 15°C to 30°C (59°F to 86°F)

Inactive ingredients

edible white ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol

Questions or comments? 

1-800-706-5575

Principal Display Panel

Premier Value

Nighttime Sinus and Congestion

NDC number 68016-733-16

16 Liquid Capsule

INGREDIENTS AND APPEARANCE

NIGHT TIME SINUS AND CONGESTION 
acetaminophen, doxylamine succinate, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-733
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	47A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-733-16	8 in 1 BLISTER PACK
1		2 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/12/2015

Labeler - Chain Drug Consortium, LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	analysis(68016-733) , manufacture(68016-733)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited Strathroy		243944050	analysis(68016-733) , manufacture(68016-733)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		969852743	pack(68016-733)